Sourcing Compliance Management Lead

2 weeks ago

New York, United States Pfizer Full time

ROLE SUMMARY

The SCM Lead will support the delivery of a robust vendor engagement infrastructure (processes, systems/tools) for Business & Transformation Office customers in support of Safety, Regulatory, and Clinical Development in areas such as: business process support, vendor assessment & onboarding, monitoring sourcing strategy framework, sourcing and contract compliance and audit/inspection support.

ROLE RESPONSIBILITIES

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.
- Monitor and support compliance with sourcing and contracting
- Support audit/inspections/litigation readiness and responses
- Support development and execution of suite of vendor engagement tools including vendor assessment, vendor utilization, study awards and other tools to enable better transparency, study and functional line planning
- Support the review, oversight, monitoring and remediation of QMS09 business process
- Support the development of a fit for purpose vendor assessment process
- Manage and triage of early stage interests for vendor engagement where there might be a need for vendor assessment
- Provide guidance and expertise to teams for required vendor onboarding and engagement activities
- Support evolution and execution of fit-for-purpose governance programs which hold vendor accountable to relationship commitments maintains line of sight into performance and quality issues
- Design new processes for Business Development engagements and FCPA processes and train resources to champion, execute and oversee respective areas
- Manage direct report(s) within SCM Team

QUALIFICATIONS

**Education**:

- Bachelor’s degree is required with 15 years relevant experience in clinical trial conduct and clinical trial operations; an advanced degree is preferred.

Prior Experience / Attributes Preferred:

- At least 15 years clinical trial experience with Bachelor’s Degree (12 years with Master’s Degree). Extensive background in clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, monitoring, clinical and regulatory operations
- At least 5 years people management/supervisory experience
- Demonstrated experience and understanding of risk management within clinical trial execution
- Business experience and understanding of vendor engagement and contracting processes
- Good Clinical Practice (GCP), quality systems infrastructure, and 3rd party supplier management experience
- Ability to support document requests and create tools for internal audits, regulatory agency inspections, and litigation
- Excellent analytical management skills
- Demonstrated sound business acumen and judgement
- Models key behaviors of customer focus; integrity and trust
- Deals with ambiguity is creative and has ability to adapt in real-time
- Drives for results, plans, manages and measures work
- Multi-tasking; prioritizing; coping with high work volume
- Ability to meet tight deadlines
- Ability to work autonomously as well as working within a team
- Demonstrated experience to manage and improve large complex processes and/or business operating models

PHYSICAL/MENTAL REQUIREMENTS
- NA

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Occasional travel for business/team meetings.
- During exceptional circumstances, need to work non-traditional hours (such as during a regulatory agency inspection)

OTHER INFORMATION
- Eligible for employee referral bonus

ORGANIZATIONAL RELATIONSHIPS
- Interacts directly with Business & Transformation Office customers and vendors in support of Safety, Regulatory, and Clinical Development
- Close partnership with Clinical Operations, Procurement, Legal, Corporate Compliance, Clinical Development Quality, Corporate Audit, and Medical Quality Assurance

Work Location Assignment: On premise

Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount o

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